Uses of Phantom Sensations Induced by Global and Local Modifications of the Prosthetic Socket as Somatosensory Feedback During Walking in Lower Limb Amputees

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUnion de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est

About this trial

Following lower-limb amputation, the loss of somatosensory information from the missing limb renders walking less automatic, more cognitively demanding, and often asymmetric, which can lead to secondary pathologies.

Hypothesis: This study is based on the hypothesis that phantom limb sensations (PLS), when coherent with the prosthetic device's movements and the phases of the gait cycle, can compensate for the loss of somatosensory feedback and thereby improve locomotion for individuals with amputation. It is further hypothesized that it is possible to artificially induce these coherent and useful sensations, notably through "referred sensations" elicited by stimulation of the residual limb (e.g., via the prosthetic socket).

Objectives: The project aims to:

* Determine whether the natural presence of phantom limb sensations during walking impacts gait parameters. * Confirm in a larger patient population that modifications to the prosthetic socket can induce or enhance phantom sensations that are perceived as useful for walking. * Investigate whether these perceptual changes (induced or enhanced) are associated with objective, measurable improvements in gait quality.

Eligibility criteria

Qualifiers

Major lower limb amputation

Understand and be able to express oneself in the French language (for semi-structured interviews)

Affiliated with a social security scheme

No major surgery on the lower limbs for at least 3 years

Disqualifiers

History of psychiatric disorders

Pregnant or breastfeeding woman

Minor

Adult subject to a legal protection measure

Trial design

Treatments tested in this trial

  • Gait analysis
  • Mapping of referred sensations.
  • Exploration of the areas of the brain activated during referred sensations
  • Evaluation of the effects of socket modifications on phantom sensations and walking
  • Phantom limb interview

Treatment groups

228 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est

Lead sponsor

Clinique Chantecler

Collaborator

Centre Orthopédique Maguelone

Collaborator

Centre Helio Marin

Collaborator

Institut universitaire de réadaptation Valmante Sud

Collaborator

Institut des Sciences du Mouvement

Collaborator